Meeting Minutes for SPL Generic Sub-Team Meeting November 17, 2008, 1-2 pm ET 1.DUNS Numbers - Tom Marsden from Dunn & Bradstreet (D&B) will attend this teleconference to answer questions about obtaining DUNS numbers for SPL R4 and to discuss our issues below: Getting your companies DUNS number is free.Getting other companies DUNS numbers - $429 annual + $3.55 per number.How much do we pay if we only need one or two numbers? We, the SPL producers, need to find the exact way of getting external/other company duns number from D&B.A flowchart with contacts would be useful. The Generic Sub Team requests a dedicated group at D&B for these requests. Tom Marsden spoke at the meeting in the first half hour. He agreed that obtaining your DUNS number is free for any location worldwide. What can D&B do to design a faster process for other firms, API, Suppliers etc.?
1.Tom suggested that a partnering solution with D&B was in the works to provide DUNS numbers to utilizing companies that are technology providers.They will partner with companies and can provide the DUNS numbers with or without conversions.Several vendors spoke up that they would like to be included.Tom asked who he can contact – list of vendors is on the Wiki site.The vendors would set their own prices. 2.D&B is considering a call center and a dedicated group with one number that industry can call.They will be able to identify if a company has a DUNS number and create a DUNS # for a company, if needed.They will also bring the price down from the $429/year and $3.55/DUNS number requested.This amount has not been determined yet.We will be able to request this number via phone or e-mail.This call center would not try to sell us anything else; just provide what is needed to obtain a DUNS number. When a pharmaceutical representative is getting their information – the requester should provide information for collection and updating of the D&B information. DUNS number will also be available from filings at the FDA site. Tom’s presentation is on the Generic’s group page on the Wiki. Tom Marsden – marsdent@dnb.com We discussed timeliness for setting up the call center.Tom suggested the beginning of next year and we requested that it be ready at the beginning of December so that companies can ready themseles for the June 1, 2009 date. 2.Meeting minutes from 11/03/08, discussion of GPhA and DIA Workshops – any comments?Will be posted on the Wiki site. The 11/03/08 minutes are posted on the Wiki. FDA had made several comments on the discussion. The most critical for us is: Source Code (NDC #’s first two sections) is OK to use for DUNS Number!
Facts@FDA will be established and will be a combination of Drugs@FDA and the Daily Med.It will be owned by FDA and will be the FDA official view.We have asked that there be a section that shows if labeling is approved – this is very important for Generic companies in particular. 3.One member has suggested changing these meetings to once every 4th week instead of every other week.As we do not get many agenda items, I think this would be a good idea.Please remember this is a working meeting.You should both attend and participate in the meetings. Regarding the meeting schedule: We will keep the meetings scheduled at every 2 weeks.If no new agenda items, the meeting will be cancelled.We will try to cancel meeting by the Friday before the meeting.If you need to discuss something, please let us know via email. 4.Comment to FDA – it would be very helpful to show the DUNS# on the site: During the Generics Subteam teleconference this afternoon, there was a discussion regarding the potential inclusion of the DUNS# on the FDA website for Annual Registration.Since this site is routinely used for the confirmation of registrations, the addition of the DUNS# would be very well received.The simple listing of the DUNS# should not be considered proprietary as it does not disclose any financial information, just as the FEI # was public knowledge.Please keep in consideration the addition of the DUNS# to the site. DUNS number will be available from filings at the FDA site per D&B. 5.The Draft Survey is coming – we will be testing it.It will be anonimized and the information will be shared with all. The final draft of the survey has gone out for review.This SPL Work group, Generics, will be the initial testers.It will be available online from the Wiki.We will let you know as soon as it is available. 6.Federal Register notice issue – We have not received any comments.They are due to GPhA on Monday the 17th.We will not comment if we do not get any feedback. Original request from Virginia: Has everyone seen this?It breaks down how much of a burden the ER/DL (Electronic Registration/Drug Listing) is.Please let me know if you think this is realistic considering how much effort has been put into the project so far. FDA has issued an AICA with annual burden estimates for ER/DL - they responded to draft guidance comments - they did not change estimates that appeared in the draft guidance. Comments are due Nov 24, 2008 - Do we want to comment through GPhA?If so, we must have comments to them by Monday, November 17 (our next meeting.)If you have any comments please send them to me prior to the meeting so we can discuss them. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-25338.pdf We did not receive any comments so we will not be commenting to the FDA as a group. 7.Two Questions sent in for discussion: a.How to drug list export only products, those with foreign language labeling.Will we be required to create Content of Labeling files for these foreign language inserts?Would they be placed on DailyMed?I would think not… b.Will the Committee be addressing the request for comment published in the FR on 10/23/08?As I read this document, the FDA seems to have ignored every comment and simply stands by the initial statements. We will not comment since we did not receive any comments from Generic Team Members except for the one that Hospira is already sending in. VH 8.Any other business. Who does drug listing: A point was made at the meeting that Mike Fahmy is working on a list of different conditions which will lead to different entities providing the listing.Scenario descriptions would be helpful, so that a flowchart or table or both may be provided. Several questions posed to Lonnie Smith after the meeting that I wanted to share with the group: Q1. My company is a contract manufacturer of products for various companies. Right now, for contract customers, my company drug lists a product as the manufacturer and the customer drug lists as the distributor. One customer, however, said that FDA will in the future require only distributors of the product to drug list and it will no longer be necessary for the manufacturer to drug list for the product. I’m wondering whether or not this is true. I didn’t see anything in the guidance to this effect but thought I should double check anyway. A1. The FDA requires the Manufacturer to do product listing OR the Distributor can elect to list for both. The current paper way has both doing the listing, but the new way via electronic drug listing should only have one doing the listing.So if the Manufacturer lists, the Distributor should not.Each product should only be listed one time. Q2. A question came up here.For AI suppliers, if we obtain them through an agent, does the drug listing process want the DUNS number for the actual manufacturer or the agent, or both? A2. For API suppliers obtained through a distributor/agent, the drug listing process needs the DUNS number from the API manufacturer, not the distributor/agent unless they are repacking, relabeling, etc.If they are doing one of those you will need both numbers.If you are not sure who the manufacturer is through the distributor you can use the source code instead of the DUNS number. I verified the above answers with Lonnie.We will add this question/response to the list we are putting together for the wiki site. (VH) Next meeting Planned December 1, 2008, 1-2 PM ET.Please send agenda items to:Virginia.Hogan@TEVAUSA.com
Generic Sub Team Roster Attendance for 11/17/08 Meeting
November 17, 2008, 1-2 pm ET
1. DUNS Numbers - Tom Marsden from Dunn & Bradstreet (D&B) will attend this teleconference to answer questions about obtaining DUNS numbers for SPL R4 and to discuss our issues below:
Getting your companies DUNS number is free. Getting other companies DUNS numbers - $429 annual + $3.55 per number. How much do we pay if we only need one or two numbers?
We, the SPL producers, need to find the exact way of getting external/other company duns number from D&B. A flowchart with contacts would be useful.
The Generic Sub Team requests a dedicated group at D&B for these requests.
Tom Marsden spoke at the meeting in the first half hour.
He agreed that obtaining your DUNS number is free for any location worldwide.
What can D&B do to design a faster process for other firms, API, Suppliers etc.?
1. Tom suggested that a partnering solution with D&B was in the works to provide DUNS numbers to utilizing companies that are technology providers. They will partner with companies and can provide the DUNS numbers with or without conversions. Several vendors spoke up that they would like to be included. Tom asked who he can contact – list of vendors is on the Wiki site. The vendors would set their own prices.
2. D&B is considering a call center and a dedicated group with one number that industry can call. They will be able to identify if a company has a DUNS number and create a DUNS # for a company, if needed. They will also bring the price down from the $429/year and $3.55/DUNS number requested. This amount has not been determined yet. We will be able to request this number via phone or e-mail. This call center would not try to sell us anything else; just provide what is needed to obtain a DUNS number.
When a pharmaceutical representative is getting their information – the requester should provide information for collection and updating of the D&B information.
DUNS number will also be available from filings at the FDA site.
Tom’s presentation is on the Generic’s group page on the Wiki.
Tom Marsden – marsdent@dnb.com
We discussed timeliness for setting up the call center. Tom suggested the beginning of next year and we requested that it be ready at the beginning of December so that companies can ready themseles for the June 1, 2009 date.
2. Meeting minutes from 11/03/08, discussion of GPhA and DIA Workshops – any comments? Will be posted on the Wiki site.
The 11/03/08 minutes are posted on the Wiki.
FDA had made several comments on the discussion. The most critical for us is:
Source Code (NDC #’s first two sections) is OK to use for DUNS Number!
Facts@FDA will be established and will be a combination of Drugs@FDA and the Daily Med. It will be owned by FDA and will be the FDA official view. We have asked that there be a section that shows if labeling is approved – this is very important for Generic companies in particular.
3. One member has suggested changing these meetings to once every 4th week instead of every other week. As we do not get many agenda items, I think this would be a good idea. Please remember this is a working meeting. You should both attend and participate in the meetings.
Regarding the meeting schedule:
We will keep the meetings scheduled at every 2 weeks. If no new agenda items, the meeting will be cancelled. We will try to cancel meeting by the Friday before the meeting. If you need to discuss something, please let us know via email.
4. Comment to FDA – it would be very helpful to show the DUNS# on the site:
During the Generics Subteam teleconference this afternoon, there was a discussion regarding the potential inclusion of the DUNS# on the FDA website for Annual Registration. Since this site is routinely used for the confirmation of registrations, the addition of the DUNS# would be very well received. The simple listing of the DUNS# should not be considered proprietary as it does not disclose any financial information, just as the FEI # was public knowledge. Please keep in consideration the addition of the DUNS# to the site.
DUNS number will be available from filings at the FDA site per D&B.
5. The Draft Survey is coming – we will be testing it. It will be anonimized and the information will be shared with all.
The final draft of the survey has gone out for review. This SPL Work group, Generics, will be the initial testers. It will be available online from the Wiki. We will let you know as soon as it is available.
6. Federal Register notice issue – We have not received any comments. They are due to GPhA on Monday the 17th. We will not comment if we do not get any feedback.
Original request from Virginia:
Has everyone seen this? It breaks down how much of a burden the ER/DL (Electronic Registration/Drug Listing) is. Please let me know if you think this is realistic considering how much effort has been put into the project so far.
FDA has issued an AICA with annual burden estimates for ER/DL - they responded to draft guidance comments - they did not change estimates that appeared in the draft guidance.
Comments are due Nov 24, 2008 - Do we want to comment through GPhA? If so, we must have comments to them by Monday, November 17 (our next meeting.) If you have any comments please send them to me prior to the meeting so we can discuss them.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-25338.pdf
We did not receive any comments so we will not be commenting to the FDA as a group.
7. Two Questions sent in for discussion:
a. How to drug list export only products, those with foreign language labeling. Will we be required to create Content of Labeling files for these foreign language inserts? Would they be placed on DailyMed? I would think not…
b. Will the Committee be addressing the request for comment published in the FR on 10/23/08? As I read this document, the FDA seems to have ignored every comment and simply stands by the initial statements.
We will not comment since we did not receive any comments from Generic Team Members except for the one that Hospira is already sending in. VH
8. Any other business.
Who does drug listing:
A point was made at the meeting that Mike Fahmy is working on a list of different conditions which will lead to different entities providing the listing. Scenario descriptions would be helpful, so that a flowchart or table or both may be provided.
Several questions posed to Lonnie Smith after the meeting that I wanted to share with the group:
Q1. My company is a contract manufacturer of products for various companies. Right now, for contract customers, my company drug lists a product as the manufacturer and the customer drug lists as the distributor. One customer, however, said that FDA will in the future require only distributors of the product to drug list and it will no longer be necessary for the manufacturer to drug list for the product. I’m wondering whether or not this is true. I didn’t see anything in the guidance to this effect but thought I should double check anyway.
A1. The FDA requires the Manufacturer to do product listing OR the Distributor can elect to list for both.
The current paper way has both doing the listing, but the new way via electronic drug listing should only have one doing the listing. So if the Manufacturer lists, the Distributor should not. Each product should only be listed one time.
Q2. A question came up here. For AI suppliers, if we obtain them through an agent, does the drug listing process want the DUNS number for the actual manufacturer or the agent, or both?
A2. For API suppliers obtained through a distributor/agent, the drug listing process needs the DUNS number from the API manufacturer, not the distributor/agent unless they are repacking, relabeling, etc. If they are doing one of those you will need both numbers. If you are not sure who the manufacturer is through the distributor you can use the source code instead of the DUNS number.
I verified the above answers with Lonnie. We will add this question/response to the list we are putting together for the wiki site. (VH)
Next meeting Planned December 1, 2008, 1-2 PM ET. Please send agenda items to: Virginia.Hogan@TEVAUSA.com
Generic Sub Team Roster
Attendance for 11/17/08 Meeting
Generic Sub Team Leader
Generics Sub Team Co Leader
OTC Sub Team co-leader
Distribution only